Sulfamylon

INDICATIONS

SULFAMYLON® (mafenide acetate) For 5% Topical Solution is indicated for use as an adjunctive
topical antimicrobial agent to control bacterialinfection when used under moist
dressings over meshed autografts on excised burn wounds.

DOSAGE AND ADMINISTRATION

SULFAMYLON® (mafenide acetate) For 5% Topical Solution: Directions for Preparation
of the Solution: SULFAMYLON® (mafenide acetate) (mafenide acetate) For 5% Topical Solution
is supplied as a sterile powder and is to be reconstituted with Sterile Water
for Irrigation, USP or 0.9% SodiumChloride Irrigation, USP. Aseptic techniques
should be observed during preparation of the solution. Pre- measured quantities
of 50 g of mafenide acetate powder are provided in sterile packets. The entire
quantity of SULFAMYLON® (mafenide acetate) should be emptied into a suitable container which
contains 1000 mL of Sterile Water for Irrigation, USP or 0.9% Sodium Chloride
Irrigation, USP and mixed until completely dissolved. The reconstituted solution
may be held up to 28 days after preparation if stored in unopened containers.
ONCE A CONTAINER IS OPENED, ANY UNUSED PORTION SHOULD BE DISCARDED AFTER
48 HOURS. Store the reconstituted solution at 20° to 25°C (68°
to 77°F). Limited storage periods at 15° to 30°C (59° to 86°F)
are acceptable. Not for Injection - For Topical Use Only.

Directions for Use of the Solution: The grafted area should be
covered with one layer of fine mesh gauze. An eight-ply bum dressing should
be cut to the size of the graft and wetted with SULFAMYLON® (mafenide acetate) 5% SOLUTION
using an irrigation syringe and/or irrigation tubing until leaking is noticeable.
If irrigation tubing is used, the tubing should be placed over the bum dressing
in contact with the wound and covered with a second piece of eight-ply dressing.
The irrigation dressing should be secured with a bolster dressing and wrapped
as appropriate. The gauze dressing should be kept wet. In clinical studies,
this has been accomplished by irrigating with a syringe or injecting the solution
into the irrigation tubing every 4 hours or as necessary. If irrigation tubing
is not used, the gauze dressing may be moistened every 6-8 hours or as necessary
to keep wet.

Wound dressings maybe left undisturbed, except for the irrigations, for up to five days. Additional soaks may be initiated until graft take is complete. Maceration of skin may result from wet dressings applied for intervals as short as 24 hours. Treatment is usually continued until autograft vascularization occurs and healing is progressing (typically occurring in about 5 days). Safety and effectiveness have not been established for longer than 5 days for an individual grafting procedure.

If allergic manifestations occur during treatment with SULFAMYLON® (mafenide acetate) 5% SOLUTION,
discontinuation of treatment should be considered. If acidosis occurs and becomes
difficult to control, particularly in patients with pulmonarydysfunction, discontinuing
the soaks with the mafenide acetate solution for 24 to 48 hours may aid in restoring
acid-base balance (see PRECAUTIONS section).
Dressing changes and monitoring the site for bacterial growth during this interruption
should be adjusted accordingly.

HOW SUPPLIED

SULFAMYLON® (mafenide acetate, USP) For 5% Topical Solution is available
in packets (NDC 51079-624-84) containing 50 g of sterile mafenide acetate to
be prepared using 1000 mL Sterile Water for Irrigation, USP or 0.9% Sodium Chloride
Irrigation, USP. (See DOSAGE AND ADMINISTRATION: SULFAMYLON® (mafenide acetate) For
5% Topical Solution: Directions for Preparation of the Solution.) The packets
are supplied as follows:

Carton of five 50 g packets

NDC 51079-624-85

Recommended Storage:

Packets - Store PACKETS in a dry place at room temperature 15° to
30°C (59° to 86°F).